Job ScopeResponsible for evaluating and optimizing manufacturing, and CAPA processes to improve product consistency ensure regulatory compliance and increase productivity. Responsible for end-to-end validation lifecycles for new and existing products while applying strong business acumen to balance quality requirements with operational efficiency. Supports all applicable regulations including but not limited to FDA, ISO13485.
Responsibilities and Duties- Review of design, manufacturing, purchasing, and test documentation to ensure quality requirements are fulfilled.
- Review specifications, operation instructions, sheets, process procedures, test procedures, inspection and test analysis.
- Provide leadership in and employ advanced quality planning techniques (FMEA, Capability Studies, Measuring and Test Equipment Studies, Product Validation and Reliability Test)
- Assist in determining process/equipment capabilities.
- Assist in the development of process flow diagrams and perform gap analyses on current controls versus required controls.
- Investigate the root cause of external and internal non-conforming products.
- Drive corrective and preventive actions and verifications of effectiveness such as actions for customer complaints, internal audits, and internal and external suppliers non-conformance.
- Perform assessments of process-related risks, bridging the gap between technical quality requirements and business goals to support strategic decision-making.
- Assist in the development of inspection procedures and justified sample plans.
- Develop and maintain systems to collect, analyze, and report data reflecting status of product and process and provide recommendation to improve.
- Represent quality on new product development teams for design transfer with guidance from more senior quality engineers or management.
- Apply project management principles to lead continuous improvement and Lean initiatives.
- Perform other duties as assigned.
Education, Experience and Qualifications- Bachelor's Degree and/or equivalent experience in a Life Sciences discipline (Biochemistry, Chemistry, Microbiology, etc.) or Engineering discipline (Mechanical, Electrical or Industrial Engineering).
- 2+ Years related experience in IVD, medical, pharmaceutical, or other related industry.
- Proven experience in Process, Product, and/or Method Validation is required.
Licenses and Certifications- ASQ Certified Quality Engineer preferred.
Training and Skills- Must have a thorough understanding of statistical quality control, statistical process control, Corrective Action Process, and their application manufacturing as a problem identification and resolution tool.
- Proficient in Advanced SPC, Quality Analysis Tools (Taguchi, Fishbone) & DOE.
- FDA Process Validation Techniques preferred
- Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
- Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
- Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory and factor analysis.
- Ability to define problems, collect data, establish facts, and draw valid conclusions.
- Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
What We OfferDiasorin offers a competitive rewards package focused on your overall well-being. We are proud to offer a comprehensive plan of health benefits, retirement and financial wellbeing, time off programs, wellbeing support and perks. Benefits may vary by role, country, region, union status, and other employment status factors. You may also be eligible to participate in an annual incentive program. An incentive award, if any, depends on various factors, including, individual and organizational performance
Diasorin is committed to building a workplace where people feel empowered to contribute ideas, take ownership, and grow their careers. We believe diverse perspectives strengthen innovation and help us deliver meaningful impact for patients and customers worldwide.
